MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® RUBBER UTILITY CATHETER

Model Number	277716
Medical Device Problem Code	Material Too Soft/Flexible (4007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
Event or Problem Description
It was reported that the rubber piece in the intermittent catheter where the fluid was supposed to go through was thin, and it bends not allowing the fluid to go straight through.Customer also stated that they had gone through several catheters because of the same issue.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be due to "operator error".It is unknown whether the device had met relevant specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.Although the product family is unknown, the intermittent catheter ifus are found to be adequate based on past reviews.H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : the device was not returned.
Event or Problem Description
It was reported that the rubber piece in the intermittent catheter where the fluid was supposed to go through was thin, and it bends not allowing the fluid to go straight through.Customer also stated that they had gone through several catheters because of the same issue.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a through f - the information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.H3 other text : the device was not returned.
Event or Problem Description
It was reported that the rubber piece in the intermittent catheter where the fluid was supposed to go through was thin, and it bends not allowing the fluid to go straight through.Customer also stated that they had gone through several catheters because of the same issue.
Additional Manufacturer Narrative
The reported event was inconclusive.No sample was returned for evaluation.A potential root cause for this failure could be due to "operator error".The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: ¿rubber utility catheter x-ray opaque rubber warning: do not use ointments or lubricants having a petrolatum base.They will damage latex.This is a single use device.Do not resterilize any portion of this device.Reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury, illness or death of the patient.Visually inspect the product for any imperfections or surface deterioration prior to use.Storage: store catheters at room temperature away from direct exposure to light, preferably in the original box.Caution: this product contains natural rubber latex which may cause allergic reactions caution: federal (usa) law restricts this device to sale by or on the order of a physician.For urological use only.U.S.Product.Packaged in mexico.¿ the device was not returned.
Event or Problem Description
It was reported that the rubber piece in the intermittent catheter where the fluid was supposed to go through was thin, and it bends not allowing the fluid to go straight through.Customer also stated that they had gone through several catheters because of the same issue.

• Brand Name: BARD® RUBBER UTILITY CATHETER
• Common Device Name: RUBBER UTILITY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 12468662
• Report Number: 1018233-2021-05658
• Device Sequence Number: 4738723
• Product Code: KOD
• UDI-Device Identifier: 00801741034114
• UDI-Public: (01)00801741034114
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/15/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/31/2025
• Device Model Number: 277716
• Device Catalogue Number: 277716
• Device Lot Number: NGFP0934
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/24/2021
• Supplement Date Received by Manufacturer: 12/23/2021; 02/18/2022; 03/15/2022
• Initial Report FDA Received Date: 09/14/2021
• Supplement Report FDA Received Date: 01/12/2022; 03/09/2022; 04/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown